酮康唑乳膏的质量标准研究

Study on quality control of ketoconazole cream

目的:建立酮康唑乳膏的质量标准研究。方法:利用薄层色谱法对酮康唑乳膏中有关物质进行检查,同时采用紫外分光光度法并以酮康唑为标准对制剂中的酮康唑进行含量测定。结果:供试品色谱与对照品相应位置显相同颜色斑点,且杂质斑点不超过1.5%。在定量分析中,测定酮康唑的线性范围为4.08～32.64μg/mL,与吸收度呈良好线性关系,A=0.0269C-0.0003,r=0.99993;平均回收率99.7%,RSD=0.2%;样品测定均在质量控制合格范围内。结论:该法简便易行,重现性好,结果可靠,可作为该制剂的质量控制标准。

Objective：To establish a new method for quality standard of ketoconazole cream.Methods：Ingredients of ketoconazole cream was determined by thin-layer chromatography（TLC）,and the content of ketoconazole was evaluated with ultraviolet spectrophotometry.Results：Chromatography shown color spots of the tested sample was the same as the standard ketoconazole at corresponding position,and spots of impurities was less than 1.5%.Quantitative analysis showed that linear range of ketoconazole from the tested sample was 4.08 32.64 μg / mL,absorbance was linear,A=0.026 9C-0.000 ,r=0.999 93;and the average recovery was 99.7%,RSD = 0.2%.All parameters were in accord with the quality standard.Conclusion：This method is simple,reproducible,reliable,and can be used for quality control of ketoconazole cream.